drugset / Trial / NCT01081769
Prevention of Relapse With Injectable Paliperidone Palmitate Versus Oral Antipsychotics
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to assess the efficacy (how well the drug works; primarily through the time to relapse) of long-acting injectable paliperidone palmitate compared to treatment as usual with orally administered antipsychotics in monotherapy over 24 months in the treatment of recently diagnosed (1-5 years since diagnosis) schizophrenia.
Timeline
- Start
- 2010-02
- Primary completion
- 2013-02
- Completion
- 2013-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | paliperidone palmitate | Unknown | 25 mg | Intramuscular |
| Subject | paliperidone palmitate | Unknown | 50 mg | Intramuscular |
| Subject | paliperidone palmitate | Unknown | 75 mg | Intramuscular |
| Subject | paliperidone palmitate | Unknown | 100 mg | Intramuscular |
| Subject | paliperidone palmitate | Unknown | 150 mg | Intramuscular |
| Comparator | Aripiprazole | Other / unclassified | — | Oral |
| Comparator | Haloperidol | Other / unclassified | — | Oral |
| Comparator | Olanzapine | Small molecule | — | Oral |
| Comparator | Paliperidone ER | Unknown | — | Oral |
| Comparator | Quetiapine | Small molecule | — | Oral |
| Comparator | Risperidone | Other / unclassified | — | Oral |